Rapid-I Kit
The Rapid-i Kit is a single-use cryopreservation device for containing, vitrifying and storing human embryos and mature oocytes. A small hole near the end of a plastic stick holds one to…
The Rapid-i Kit is a single-use cryopreservation device for containing, vitrifying and storing human embryos and mature oocytes. A small hole near the end of a plastic stick holds one to five embryos or oocytes in a 30 nL drop of vitrification medium through surface tension.
The loaded stick fits inside a protective straw that prevents direct contact with liquid nitrogen. The straw has a stainless steel weight to maintain its orientation and is sealed at the open end with an ultrasonic sealing device.
Loading Components
The stick is made from polymethyl methacrylate and has a flat side to aid orientation during loading. A separate steel rod keeps the straw straight during precooling and is removed before the loaded stick is inserted. The kit is supplied sterile.
Who Else Makes It
Concentrated in Guangdong (8), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Boomingshing Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Guangzhou Hehong Biotech Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Vitrolife Sweden AB, Sweden |
|---|---|
| FDA product code | MQK |
| Device type | Labware, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Manufacturer |
| 510(k) | K181461 |
| Record published | 2016-09-13 |
| Record revised | 2023-01-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 14406 | 20 | In distribution | |
| 14421 | 20 | In distribution | |
| 14422 | 20 | In distribution | |
| 14420 | 20 | In distribution | |
| 14419 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cryotec | Reprolife Inc. | 20 |
| VitriGuard | Origio A/S | 16 |
| G-Vitri™ Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 15 |
| ZyMot | DxNow Inc. | 10 |
| LensHooke Sperm Separation Device | Bonraybio Co., Ltd. | 9 |
| cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 9 |
| LifeGlobal® GPS® Dishware | Coopersurgical, Inc. | 7 |
| LifeGlobal® GPS® Dishware | LifeGlobal Group, LLC | 7 |
| Nest VT | Cook Incorporated | 5 |
| Surestrip | Allwin Medical Devices, Inc. | 5 |
| Minvitro Vitrification Straw | Guangzhou Hehong Biotech Co., Ltd. | 5 |
| Surelock | Allwin Medical Devices, Inc. | 5 |
Showing 12 of 102. All products under Labware, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181461 | 2019-01-04 |
| K140207 | 2014-12-18 |
| K090832 | 2009-12-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.